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CALM Patterns, Version 01.00.00

by Lms Medical Systems, Ltd.

510(k) K040788

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040788 Date8 Feb 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HGM
FDA applicant
Lms Medical Systems , Ltd.
Device Class
Class II
Regulation
21 CFR Part 884.2740
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

CALM Patterns, Version 01.00.00 is a perinatal monitoring system intended for use in obstetrics and gynecology. It is classified under regulation number 884.2740 and product code HGM as an obstetrical and gynecological monitoring device. The system is designed to support clinical monitoring during pregnancy and related procedures.

The device is regulated under FDA 510(k) clearance with decision number K040788 and was determined to be substantially equivalent. It is manufactured by Lms Medical Systems, Ltd., located in Montreal, Quebec, Canada. The device is associated with multiple registration and FEI numbers and falls under device class 2.

Other devices from Lms Medical Systems, Ltd.

  • Calm

    Class II

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is CALM PATTERNS used for?

    CALM PATTERNS is a perinatal monitoring system designed for use in obstetrics and gynecology. It supports clinical monitoring during pregnancy and related procedures, functioning as an obstetrical and gynecological monitoring device.

  • Who manufactures this device?

    CALM PATTERNS is manufactured by Lms Medical Systems, Ltd., a company located in Montreal, Quebec, Canada. The device is produced under their quality and regulatory compliance systems.

  • What regulatory pathway did this device follow?

    CALM PATTERNS was cleared through the FDA 510(k) premarket notification process. It received a substantially equivalent determination under decision number K040788, confirming it met the necessary safety and effectiveness standards for its device class.

  • Is this device single-use or reusable?

    The device data does not specify whether CALM PATTERNS is single-use or reusable. This information would typically be found in the manufacturer's labeling or instructions for use, which are not included in the provided regulatory summary.

  • What device class and regulation does it fall under?

    CALM PATTERNS is classified as a Class II medical device under FDA regulation number 884.2740 and product code HGM. This classification places it under moderate risk controls, requiring special controls for safety and effectiveness.